This special supplement includes eight articles that explore new ways for social investors to spur innovations that create better, faster, and less expensive health care in the United States. The supplement was sponsored by the California HealthCare Foundation.

In 2010, BeWell Mobile faced a dilemma
all too common among startups in
the health care field: how to fund the
growth of breakthrough innovations
that both lower costs and improve the standard
of care when the patients and providers
who often benefit the most have the
least ability to pay.

The San Francisco company develops
customized disease management software
that operates on devices like cell phones.
In an eight-month pilot study with the San
Mateo Medical Center, funded by the California
HealthCare Foundation, 50 bilingual,
uninsured teens with severe asthma
recorded their symptoms by phone at least
once a day using BeWell’s technology. The
real-time feedback, reminders, and other
interventions they received in response
caused the patients’ drug compliance to
more than double, their need for rescue
medications to be cut in half, and their visits
to the emergency room and their days of
missed school to fall dramatically.1

In most fields, results like these would
have had investors beating down the doors.
But despite the promise of its technology,
BeWell hasn’t been able to demonstrate a
business model that resonates with venture
capitalists. In the current health care system,
clinicians aren’t reimbursed when poor
patients on Medicaid avoid going to the hospital—only when they receive care. In effect,
Medicaid accrued the benefits of keeping
the pilot program’s patients healthier and
reducing the overall cost of their care, while
the physicians at San Mateo Medical Center
who did the work received little financial
reward. In this scenario, it’s no wonder that
the hospital decided it couldn’t justify a longer-term investment in BeWell’s technology.

BeWell’s story illustrates the challenges
facing companies that try to enter underserved
markets, defined as low-income
people and the health care providers who
serve them. In particular, this segment
of the health care field has a significant
need for new medical technologies that
expand access to important diagnostics,
treatments, and specialty services while
reducing costs—all without sacrificing the
quality of care. Think of remote monitoring
technologies that check on the vital signs
of the elderly, people with chronic health
conditions, or those recovering from a serious
illness so as to enable providers to
intervene before a crisis occurs.

Many of these technologies have the
potential to help underserved populations
that receive care from so-called safety net
providers. Such providers serve disproportionate
numbers of the uninsured and
those on Medicaid by offering free or discounted
care. They include public hospitals,
community health centers and clinics, and
for-profit and nonprofit health care organizations.2 Because of their mission and the
socioeconomic status of the majority of patients
they serve, safety net providers face
severe resource constraints.

The problem is that traditional funders
of health care innovations, such as venture
capitalists and corporate investors, are
seeking significant rewards to compensate
for any risk they take. “Investors are looking
for unbounded upside with the least
amount of risk possible,” said Josh Makower,
founder and CEO of device incubator
ExploraMed. But, he explains, “Most investors
don’t expect to find big, unbounded opportunities
in low-resource environments.”

Medical technologies with high social
value—those with the potential to reduce
costs, improve outcomes, and increase
access for underserved populations—can
play an important role in helping safety
net providers use their resources more efficiently
to better serve millions of patients.
But these products and services may not
necessarily generate the high financial
returns that investors expect, particularly
when the benefits are misaligned, as in the
BeWell example. For this reason, many companies
have struggled to secure capital to
fund the development and commercialization
of important innovations.

This misalignment between the risks
and rewards associated with innovative new
technologies must be overcome if the United
States is to improve its health care system
significantly over the coming decade.

HOW TECHNOLOGIES GET FUNDED

Medtech innovators typically have two
choices when seeking the cash they need
to achieve scale: venture capital and corporate
investment. Venture capital is by
far the largest source of funding in the
medtech field. In 2010, for instance, US
venture capitalists invested $2.3 billion in
324 medical device startups, according to
PricewaterhouseCoopers.

Venture capital, also referred to as venture
financing, typically helps startups establish
or sustain a business with high growth
potential. A venture capitalist (VC) makes
an investment, and in exchange, the VC’s
firm receives equity in the company. The expectation
is that the investors will be able to
realize a substantial return on their money
through an “exit event,” such as selling the
company to another firm, at some point in
the future. This type of funding is especially
helpful to startup companies that do not yet
have an operating history, revenue, or significant
collateral, and therefore lack access to
other sources of capital, such as bank loans.

In the medical devices sector, VCs select
their investment opportunities using
specific criteria that help them balance the
risk-reward equation. Although every VC
takes a slightly different approach to evaluating
new technologies, there are some
common criteria that they all use, such as
the strength of the management team, the
technical feasibility of the product, and the
size of the potential market. (See “What
Venture Capitalists Look for in Medtech
Investments” below.)

In combination, these criteria assist VCs
in placing their bets. The more risk they see
as they evaluate the opportunity, the greater
the market size and potential return on investment
must be to get them interested.
Because a large portion of venture capital
deals fail to earn any return on investment,
those that succeed must compensate for the
losses. “If roughly 20 percent to 40 percent
of companies succeed, you need these companies
to make up for the capital invested
across the portfolio and generate a return for
investors,” says Mudit Jain, a partner with
venture capital firm Synergy Life Science
Partners. Returns for VC-funded companies
considered to have achieved a successful exit
range from 300 percent to 1,000 percent, or
three times to 10 times the total investment.

Another common funding source for
medtech innovators is corporate investment.
Large corporations, such as Johnson & Johnson
and Medtronic, can help fund startups
by underwriting a specific research and
development effort through a development
partnership or by investing in the company
as a traditional VC would. Corporations have
criteria similar to those that VCs use when
evaluating opportunities. Unlike venture
investors, however, corporate investors are
looking for investments that will also create
synergies with other products in their
portfolios or new opportunities aligned with
their growth strategy. If a new technology is
strategically attractive, a company may be
slightly more flexible than VCs when making
an investment.

THE TWO SIDES OF THE SAFETY NET MARKET

Unfortunately for innovators who want to
develop technologies that aid underserved
populations, VCs and corporate investors
use the same demanding criteria to evaluate
these technologies as they use to assess
mainstream commercial opportunities.
What’s more, VCs today face even greater
pressure to produce results, and they may
have less money to invest than in the past.
In combination, these factors can make it
difficult to get funding for technologies that
could benefit the safety net but pose greater
investment risk.

“The investors we represent don’t look
to us to do their humanitarian work,” says
Michael Goldberg, a partner with venture
capital firm Mohr Davidow Ventures. “They
look to our firm to generate a return on
their investments in a way that’s hopefully
compatible with their humanitarian values.
If we told them we were going to sacrifice
investment returns in any material way in
an effort to better serve the general welfare
of the US or world population, I think they
would move their money as soon as they
had the opportunity.”

When asked what advice he would give
to innovators seeking funding to meet clinical
needs in low-resource settings, William
Starling, managing director of Synergy Life
Science Partners, says bluntly: “Avoid venture
capitalists. Venture capitalists are trying
to survive. There’s just no way they’re
going to put money into efforts that don’t
meet the minimum bar for return on investment
in the current climate.”

Despite the perception that low-resource
environments can’t generate big returns, the
safety net shows some promise as a market
opportunity for commercial investors—specifically, it can be used as a launchpad
for cost-reducing technologies. As the entire
health care system becomes more cost
constrained, technologies that can reduce
spending should become more broadly appealing.
Proving the value associated with
these products under the challenging conditions
of the safety net could potentially help
them cross over into mainstream commercial
settings. In the process, it would help
establish the safety net as a preliminary
market from which companies could expand.

Innovators can also consider expanding
from the safety net into low-resource environments
abroad. “If you can actually find a
solution that makes sense in [US-based] resource-constrained environments, you may
be able to enter the true growth markets of
tomorrow,” says Ed Manicka, CEO of medical
device maker Corventis. “Specifically,
India and China are demanding low-cost
solutions that are technologically on par
with what is available in the United States.
Now, clearly, the margins are going to be
lower, but the pure scale is mind-boggling.”

Finally, the size of the underserved population,
although small compared with the
total US market, is still substantial. Medicaid
covers roughly 48 million low-income
families and another 14 million elderly and
people with disabilities. Total Medicaid
spending for fiscal 2010 was approximately
$365 billion, almost a 9 percent increase
over the previous year, and the budget is expected
to continue growing for the foreseeable
future. Although there are significant
challenges associated with reaching and
serving these patients and their providers,
the population represents a sizable opportunity
for innovators who can figure out
how to serve it profitably with high-value,
lower-cost solutions.

THE CASE OF REMOTE MONITORING

A specific class of products known as remote-monitoring and intervention technologies
illustrates the challenges and opportunities
that innovators face when they
seek venture funding for innovations that
have high social value. Although remote
monitoring can potentially reduce costs,
improve care, and increase underserved
patients’ access to specialty care, venture
investment in this area has been slow and
somewhat inconsistent.

Devices like blood pressure cuffs and glucose
monitors enable physicians and other
care providers to check and treat patients’
conditions without being physically present.
Costs can be lowered when care shifts
to a less expensive setting, such as a clinic
or a patient’s home. By keeping people out of
the hospital, these solutions can also significantly
help improve people’s quality of life.

When VCs and corporate investors
evaluate remote-monitoring technologies
using their standard investment criteria,
many innovations receive high marks for
technical feasibility. “Remote-monitoring
technologies are relatively low-tech in some
ways—I mean, it’s not like we’re putting
devices inside the body that are going to
shock a patient’s heart,” says Suneel Ratan,
a marketing, reimbursement, and government
relations executive at Robert Bosch
Healthcare, a leading corporation in the
telehealth field. Most of these products are
based on fundamental technologies that
have proved themselves in sensors, data
communications, or other fields.

Moreover, because the devices are for
external use, they pose few safety risks
for patients. As a result, they often receive
regulatory clearance through the FDA ’s
faster 510(k) review process. Most investors
favor 510(k) products over those that
require pre-market approval, and thus they
may be more attracted to remote-monitoring
innovations.

Although the technical and regulatory
risks are relatively low, several other investment
criteria have proved to be problematic
for many remote-monitoring solutions. Investors
frequently decide not to fund the
technologies because of a combination of
market and adoption risks, as well as issues
regarding business models and reimbursement.
Investors are also hesitant to commit
resources because they perceive a low potential return on investment. Each is a significant
barrier that must be overcome in order
for new technologies to move forward. (See
“Remote-Monitoring Risk Factors” below.)

The story of Health Hero Network illustrates
each of these barriers to funding, as
well as the challenges traditional investment
criteria create. At the time Health
Hero Network was established in 1998, the
Palo Alto, Calif.-based company’s primary
product was the Health Buddy System for
monitoring and improving the health of
high-risk, high-cost elderly and disabled patients
with one or more chronic conditions.

Patients used a simple, four-button
device that each day led them through
interactive sessions of six to 10 questions
customized for the person’s condition.
Primary care physicians and specialists
prescribed Health Buddy to teach patients
how to understand their conditions better,
help them change their behavior, enable the
early detection of health risks before they
escalated to an acute stage, and provide
reassurance to patients that their health
was being monitored. Health Hero Network
supplied the technology and training for
users; the health care provider set up the
basic infrastructure for receiving, interpreting,
and acting upon data transmitted
from patients’ homes.

After Health Hero Network developed
the technology, it conducted a series of
demonstration studies to prove the system’s
value. A small early study with the
health plan PacifiCare showed a 50 percent
reduction in hospital readmissions for heart
failure patients who used Health Buddy, according
to Ratan. Despite these encouraging
results, PacifiCare eventually decided to
outsource its disease management services
rather than adopt the technology.

In 2000, Health Hero Network launched
a pilot with the Veterans Administration
(VA) in Florida. The study of 900 patients
using Health Buddy found a 63 percent reduction
in hospital readmissions and an 88
percent decline in nursing home days.3Approximately
four years later, Health Hero
received its first national contract with the
VA. The agency agreed to directly fund the
purchase and use of Health Buddy technology
and related services.

Health Hero Network then approached
the Centers for Medicare & Medicaid Services
(CMS) about securing reimbursement
for its product. “The largest and most expensive
group of patients you can go after
globally is the folks on Medicare,” Ratan
says. “[Health Hero Network] had a desire
to prove that health care management interventions
with the Health Buddy would
generate a similar result in a fee-for-service
system.” The company submitted a proposal
to CMS and got approval to launch
a three-year demonstration study in 2006.
The results have not been officially released,
although Ratan described them as “jawdropping.”
CMS extended the demonstration
project in 2009, but as of this writing
has not yet decided whether to grant reimbursement
for the product.

Robert Bosch Healthcare acquired
Health Hero Network in late 2007, when
more than 20,000 people with chronic conditions
were using Health Buddy. After receiving
about $72 million in total known funding,
the company was sold for $116 million,
a return of roughly 1.6 times the investment.

In deciding to sell the company, Health
Hero’s board presumably determined that
an exit at that point was financially more attractive
for its investors than the alternative
of raising more capital in order to drive reimbursement
changes and increase market
adoption. The funding environment in 2007,
along with the company’s progress to date,
most likely made it difficult for Health Hero’s
investors to envision a compelling return
on investment from putting in more money
and extending the investment time horizon.

Other risk factors also played a role in
preventing Health Hero from raising additional
capital to commercialize the Health
Buddy product on its own. The high burden
of proof required to change physician behavior
and drive widespread market adoption
turned out to be time-consuming and costly
to the company, causing it to burn through
the funds it had already raised. Adoption was
also limited primarily to integrated health
care providers like the VA, which could benefit
from the longer-term, system-level savings
associated with such improvements as
reduced hospital admissions. Fee-for-service
providers remained unconvinced of its value,
especially without reimbursement for activities
or technologies that keep people out of
the hospital. That reduced the size of the
market in the near term. As Ratan explains:
“The premise of the Health Buddy system
is chronic care. It’s continuous, supportive,
and designed to build an individual’s capability
to take better care of himself. But the
health care system is engineered for acute
care—the incentives are structured largely
to wait until someone’s in crisis.”

STRATEGIES TO ADVANCE THE FIELD

New technologies, such as the Health Buddy
and dozens of others like it, have the potential
to reduce costs, improve health outcomes,
and increase access to the services patients
most need. But the social benefits these innovations
create are undervalued in the way
traditional VC and corporate investors make
funding decisions. Foundations, social venture
funds, individual philanthropists, and
other socially minded investors can play
an important role in correcting this market
failure by altering investor perceptions of
the risk-reward equation associated with
these technologies. They can do this in three
primary ways.

Fund Meaningful Pilot Studies to
Reduce Safety Net-Specific Risks. After
identifying the most promising technologies
with high social value, social investors
can help them succeed by underwriting and
facilitating compelling pilot studies and
clinical trials. This would directly reduce
one of the most daunting costs of bringing
promising innovations to market and could
significantly reduce the time it takes to develop
the clinical proof needed to catalyze
provider adoption.

Such studies can also be designed to improve
the attractiveness of the safety net as
a market. There’s a common perception that
safety net patients are less likely than other
populations to comply with their prescribed
treatments—including the use of technology.
Rigorous studies with results that stand up
to peer review may be able to demonstrate
that underserved populations are no less
compliant than other market segments. If
particular patient groups continue to show
difficulties with compliance, social investors
might support the piloting of innovations
to minimize these issues—for example, by
shifting the burden of treatment or testing
from the patient to the provider or by making
patient requirements more fail-safe.

To get good value from the studies they
fund, social investors must think more strategically
than they have in the past about
what to test, how to test it, and what data
should be generated. The majority of pilot
studies should include controls, produce
publishable results, and include a rigorous
economic evaluation of the technology, so
that decision makers who can influence
adoption perceive the data as credible.

To accomplish these objectives, social investors
can collaborate directly with payers
to determine the kind of value proposition
data—cost savings, improved care metrics,
and so on—they would want to see before
they would be willing to pay. Then they could
design and fund a pilot to gather those data.
In the BeWell example at the beginning of
this article, the company might have generated
greater interest from investors and
health care providers if its pilot study had
been specifically designed with the goal of
demonstrating significant value for customers and determining the return on investment
required for adoption. That, in turn,
might have eliminated some of the risks for
traditional venture investors and health care
organizations. Translational work of this
kind would help innovations get uptake in
the market and attract investment.

Change Policy. In parallel, social investors
can help address business model and
reimbursement-related risks, such as the
ones Health Hero Network faced, by urging
CMS and federal lawmakers to realign
incentives in the current reimbursement
system to support the use of technologies
that reduce costs, improve care, and increase
access, even if this means shifting the venue
or disrupting the traditional model of care.

Existing incentives for “closed” health
care providers, such as the VA, Kaiser
Permanente, and other managed care organizations
receiving fixed payments for
services, may be adequate as long as sizable,
long-term capital investments are not
necessary. But direct reimbursement for innovative
new technologies would certainly
strengthen their motivation. It would also
make the technologies more appealing to
providers that still serve fee-for-service
Medicaid and Medicare patients.

In 2011, a unique opportunity exists for
social investors to interact with the new
Center for Medicare and Medicaid Innovation,
which Congress created under the
Affordable Care Act. This division of CMS
has a mandate to test innovative payment
and service delivery models to reduce
program expenditures while preserving
or enhancing the quality of care for Medicare
and Medicaid recipients. It has been
given $10 billion in funding to explore new
payment models between 2011 and 2019,
which means that social investors are perhaps
better positioned than ever before to
collaborate with the center and influence
its policy recommendations.

Another aspect of the Affordable Care
Act that may present opportunities for social
investors to effect change is the introduction
of accountable care organizations
(ACOs). ACOs are virtual networks of doctors
and hospitals that share responsibility
for providing care to a defined population of
patients over a specific period of time. The
ACO concept is intended to make groups of
previously disconnected providers jointly
accountable for the health of their patients,
giving them stronger incentives to cooperate
and save money—for example, by
avoiding unnecessary tests and procedures.
With these new incentives, technologies
that keep patients out of the hospital may
become appealing to traditional fee-for-service
providers that previously wouldn’t
have considered them.

The details of the ACO model still remain
to be proven, but social investors can lend
valuable insights as policymakers and providers
figure out how to make the approach
work. For instance, investors who are considering
ACOs as potential buyers of medical
technologies may be concerned that they
will face long sales cycles that require approvals
by the network’s board of directors
before new products can be adopted. Social
investors can potentially anticipate such
risks and, through the pilot studies they support,
gather data aimed at shortening sales
cycles for ACOs.

Establish Dual-Market Potential. Because
subsidized business models are
rarely sustainable over the long run, social
investors have a vested interest in increasing
the crossover potential of cost-saving
technologies that have been shown to serve
safety net populations effectively. Reimbursement
reform and the advent of ACOs
will potentially increase the opportunity
for technologies optimized for the safety
net to penetrate commercial markets in
the United States. Specifically, reimbursement
reform will create incentives to encourage
the adoption of new technologies
among Medicare fee-for-service providers
beyond the safety net (with private payers
following Medicare’s lead in granting reimbursement).
Similarly, ACOs will involve
not just Medicare and Medicaid beneficiaries,
but patients with private insurance as
well, thereby giving private payers another
reason to think differently about preventive
care. By supporting these policy changes,
social investors will help establish dual US
markets for safety net innovations.

Social investors can further support
technology crossovers by coordinating networks
of VCs with an interest in investing
in overseas markets and introducing them
to technologies that reduce costs while
improving health outcomes. Outside the
United States, large emerging markets in
countries like India and China are attracting
significant attention. Some of the technologies
that have been shown to deliver
value to safety net providers may be strong
candidates for improving health care in the
developing world for tens or hundreds of
millions of customers.

FUNDING SOCIAL INNOVATIONS

When it comes to funding innovations with
high social value, social investors can use
several models. Targeted grantmaking is
perhaps the most common form of support
that foundations, philanthropists, and government
agencies offer. Innovators receive
financial support from these entities with no
expectation that they will repay the money.
With effective targeted grantmaking programs,
such as the US Small Business Innovation
Research (SBIR ) program, funding is
awarded for a specific purpose (for example,
conducting a defined pilot study) and must
be linked to a specific commercialization
plan for moving the technology to market.

Program-related investment is another
common form of funding. It has been
around since 1969, but it has become increasingly
popular over the last 10 years.
Recognizing some of the inherent limitations
of grantmaking, such as the dependence
these subsidies can create, social
investors like the Acumen Fund developed
processes for providing “social capital” to
bridge the gap between the efficiency and
scale of commercial venture capital and
the social impact of pure philanthropy.4 With these models, capital is raised from
donors (typically large foundations) and
then invested in fledgling companies with
products and services that have the potential
to generate high social impact, achieve
scale rapidly, and become self-sustaining
within five to seven years.

The companies benefiting from program-related investments might be given
loans, guarantees that allow them to access
capital through other channels, or investments
in exchange for equity. The social investor
expects to earn a return on its money,
but the rates, investment horizon, and other
terms are less stringent than traditional
venture requirements. Acumen Fund, for
example, expects that approximately half
of its investments will succeed and half will
fail. For this reason, it hopes to realize a two-times
return on its successful investments,
so that 100 percent of all capital raised from
Acumen donors can be reinvested multiple
times.5 Other entities recycling donor capital
in this way within the health care field
include the Bill & Melinda Gates Foundation,
the Robert Wood Johnson Foundation, and
the California HealthCare Foundation with
its Innovations for the Underserved fund.
(For more information about this strategy,
see the “Foundations as Investors” article.)

Social venture funds are yet another
source of capital. With this type of financing,
no donors are involved; foundations,
corporations, and high-net-worth individuals
make debt or equity investments into a
fund and become limited partners, as they
would with any private equity or venture
fund. The fund pursues a social mission,
however, in addition to seeking to generate
a financial return for its investors. “Investors
take an outsized risk for the ability to have a
social impact,” explains Raj Kundra, director
of capital markets at Acumen Fund. The
Acumen Capital Market fund has attracted
investments from such high-profile foundations
as Rockefeller and Skoll. By offering
returns, even though they might be below
market rates, fund managers are able to raise
and deploy significantly larger amounts of
capital than they could by raising donations
for grants or program-related investments.

Foundations, in turn, contribute to these
funds to help technologies with high social
value reach a point at which they are attractive
to traditional investors. As Kundra says,
the goal of impact investing is to provide
a proof of concept for interesting technologies
and then bring in new sources of capital
once these innovations are far enough along
to meet more traditional investment criteria.

A fourth funding option focuses on
commercializing innovations developed in
academic settings. From 2006 to 2011 the
Wallace H. Coulter Foundation awarded
grants of $5 million to nine universities.
The schools used the money to provide seed
funding to projects that had the potential
to generate treatments and devices that improve
human health. At Stanford University,
one of the grant recipients, 25 such projects
were funded during the five-year period. A
panel of academics, entrepreneurs, and investors
selected the projects, and each one
followed a rigorous development process
that included a detailed commercialization
analysis. Almost half of these projects
moved toward the marketplace as a result
of the funding, and they have secured $43
million in follow-on funding, with 49 percent
from nongovernment sources.

Following on the success of the program,
the Coulter Foundation established a $20
million endowment at Stanford to support
funding of such translational projects in perpetuity.
By staging its investment, the foundation
proved that a rigorous development
process can work in an academic setting to
increase the rate at which new technologies
reach the market. It also demonstrated how
such an approach can accelerate the translation
of early-stage discoveries into marketable
products. Other foundations with an
interest in supporting the development and
commercialization of products or services
that can reduce the cost of health care in environments
with limited resources—without
sacrificing quality—could potentially pursue
similar funding models.

CONCLUSION

Nearly all health care stakeholders now
believe that the future of the entire system
depends on gaining better control of rising
costs. As a result, interest is growing in innovations
that enable more efficient and
cost-effective care. Traditional investors
appear more open to funding such projects,
as long as they can generate sufficient
financial returns.

Social investors can play an important
role in this movement. They can identify opportunities
to reduce risks, change policy,
and help establish dual markets for bold,
potentially market-transforming ideas that
otherwise could struggle to raise funding
from traditional sources. They can also provide
flexible, long-term capital in the form
of targeted grants, program-related investments,
social venture funds, or endowments.
Through these mechanisms, donors, investors,
funders, providers, and innovators can
help ensure that high-impact innovations
find their way to the patients who need
them the most.

Notes

1 Agency for Healthcare Research and Quality, US Department of Health and Human Services, "Daily Patient-Provider Communication and Data Transfer Using Mobile Phones Improves Outcomes and Reduces Costs for Teens with Chronic Asthma," April 18, 2008.

5 Stanford Graduate School of Business, "Acumen Fund and Embrace: From the Leading Edge of Social Venture Investing," April 2011.

Stefanos Zenios is the Charles A. Holloway Professor
in the Stanford Graduate School of Business. His
pioneering work on maximizing the benefits of medical
technology to patients when resources are limited has
influenced policies in the United States and Europe.

Lyn Denend is the director of the Program in Healthcare
Innovation at the Stanford Graduate School of
Business. She has written numerous case studies and
papers on health care and biodesign innovation.

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